FDA.reportPublic FDA data

Skin MarkOR Regular Tip

Primary DI
09349967004074
Brand
Skin MarkOR Regular Tip
Company
THE O R COMPANY PTY LTD
Model
SMOR-R
Published
2021-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349967004074PackageGS136In Commercial Distribution
09349967004081PackageGS110In Commercial Distribution
09349967004067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349967004074093499670040749349967004074
09349967004081093499670040819349967004081
09349967004067093499670040679349967004067

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking pen, single-useA dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744346235
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19349967004965Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-35NTUE-OBPRO-35NT2023-05-26
19349967004972Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-37NTUE-OBPRO-37NT2023-05-26
19349967004989Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-40NTUE-OBPRO-40NT2023-05-26
19349967005016Uterine ElevatOR PRO with OccludOR Balloon™UE-OBPRO-32NTUE-OBPRO-32NT2023-05-26
19349967005061Uterine ElevatOR PRO with Long Handle™UE-LHPRO-32NTUE-LHPRO-32NT2023-05-26
19349967005078Uterine ElevatOR PRO with Long Handle™UE-LHPRO-35NTUE-LHPRO-35NT2023-05-26
19349967005085Uterine ElevatOR PRO with Long Handle™UE-LHPRO-37NTUE-LHPRO-37NT2023-05-26
19349967005092Uterine ElevatOR PRO with Long Handle™UE-LHPRO-40NTUE-LHPRO-40NT2023-05-26
19349967005108Uterine PositionOR PRO™UE-PLH-NTUE-PLH-NT2023-05-26
29349967004993ColpotomizOR Tube SystemCTS35-TV2023-04-04
29349967005006ColpotomizOR Tube SystemCTS45-TV2023-04-04
09349967000724LapPakORW-18W-182018-06-23
09349967001448ColpotomizOR Tube35mmC35-TV2017-11-16
09349967001479ColpotomizOR Tube45mmC45-TV2017-11-16
09349967002261Uterine ElevatOR ProUE-TVPRO-322017-07-19
09349967002292Uterine ElevatOR ProUE-TVPRO-352017-07-19
09349967002322Uterine ElevatOR ProUE-TVPRO-372017-07-19
09349967002353Uterine ElevatOR ProUE-TVPRO-402017-07-19
09349967002773Uterine ElevatOR ProUE-TVPRO-322018-01-31
09349967002803Uterine ElevatOR ProUE-TVPRO-352018-01-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G42520103680My MedicalMy Medical Store LLCFZZ2026-02-26
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26931918101047AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918108411AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918152353AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918161324AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
26931918172931AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
07540277010041RMAC SurgicalRMAC Surgical, IncFZZ2026-01-06
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00194613123291MSI Precision Specialty InstrumentsMed Saver, Inc.FZZ2025-08-01
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10714646001129Sample: Opti-TattBionix, LLCFZZ2025-06-20
40080196771852MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389025940MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12
40884389711799MEDLINEMEDLINE INDUSTRIES, INC.FZZ2025-06-12